Pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising IL-31 antagonist as active ingredient

Abstract

In a non-limiting embodiment, there is provided a pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising an IL-31 antagonist as an active ingredient, wherein the IL-31 antagonist is repeatedly administered in equal amounts at the same dosing interval to a subject with or potentially with atopic dermatitis, at 0.1 to 1000 mg/body/1 day to 12 weeks, preferably at 0.1 to 1000 mg/body/2 weeks, 0.1 to 1000 mg/body/4 weeks, or 0.1 to 1000 mg/body/8 weeks.

The invention claimed is: 
     
       1. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient, the method comprising subcutaneously administering to the patient a series of doses of an anti-human IL-31RA antibody, wherein the anti-human IL-31 RA antibody comprises an H chain variable region comprising CDR1 as set forth in SEQ ID NO: 1, CDR2 as set forth in SEQ ID NO: 2, and CDR3 as set forth in SEQ ID NO: 3, and an L chain variable region comprising CDR1 as set forth in SEQ ID NO: 4, CDR2 as set forth in SEQ ID NO: 5, and CDR3 as set forth in SEQ ID NO: 6;
 wherein the amount of the anti-human IL-31RA antibody in each individual dose in the series is 0.5 mg/kg; and 
 wherein the interval between each administration and the next is 4 weeks. 
 
     
     
       2. The method of  claim 1 , wherein the symptom is pruritus. 
     
     
       3. The method of  claim 1 , wherein, prior to the first administration of the anti-human IL-31RA antibody, the patient had experienced sleep disturbance caused by pruritus associated with atopic dermatitis, and wherein the method results in the patient's experiencing a reduction in sleep disturbance caused by pruritus, wherein the reduction in sleep disturbance is attributable at least in part to an increase in the time span from falling asleep to awakening, or a decrease in sleep onset latency, or both. 
     
     
       4. The method of  claim 1 , wherein the anti-human IL-31 RA antibody comprises a human IgG2 Fc region comprising an amino acid sequence with glutamic acid at position 419 (EU numbering). 
     
     
       5. The method of  claim 1 , further comprising administering a topical composition to the patient, wherein the topical composition comprises a topical steroid or a topical calcineurin inhibitor and is administered before, simultaneously with, or after at least one administration of the anti-human IL-31RA antibody. 
     
     
       6. The method of  claim 5 , wherein the method produces a reduction in symptoms of atopic dermatitis in the patient that is greater than the reduction in symptoms induced by treatment with the anti-human IL-31RA antibody alone. 
     
     
       7. The method of  claim 5 , wherein the method permits a lower dosage of the topical composition to be administered than would be needed when the topical composition is administered as a single agent to the patient in the absence of treatment with the anti-human IL-31RA antibody, in order to produce a comparable decrease in symptoms of atopic dermatitis. 
     
     
       8. The method of  claim 1 , wherein the anti-human IL-31RA antibody binds to and neutralizes human IL-31RA and comprises an H chain variable region as set forth in SEQ ID NO: 7 and an L chain variable region as set forth in SEQ ID NO: 8. 
     
     
       9. The method of  claim 1 , wherein the anti-human IL-31RA antibody binds to and neutralizes human IL-31RA and comprises an H chain as set forth in SEQ ID NO: 9 and an L chain as set forth in SEQ ID NO: 10. 
     
     
       10. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient, the method comprising administering to the patient an initial dose of an anti-human IL-31RA antibody, followed by subcutaneously administering two or more continuous doses of the anti-human IL-31RA antibody,
 wherein the amount of the anti-human IL-31RA antibody in each of the continuous doses is 0.5 mg/kg, 
 wherein the interval between each two sequential administrations of the continuous doses is 4 weeks, and 
 wherein the anti-human IL-31 RA antibody comprises an H chain variable region comprising CDR1 as set forth in SEQ ID NO: 1, CDR2 as set forth in SEQ ID NO: 2, and CDR3 as set forth in SEQ ID NO: 3, and an L chain variable region comprising CDR1 as set forth in SEQ ID NO: 4, CDR2 as set forth in SEQ ID NO: 5, and CDR3 as set forth in SEQ ID NO: 6. 
 
     
     
       11. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient, the method comprising administering to the patient an initial dose of an anti-human IL-31RA antibody, followed by subcutaneously administering two or more continuous doses of the anti-human IL-31RA antibody,
 wherein the amount of the anti-human IL-31RA antibody in each of the continuous doses is 30 mg/body, 
 wherein the interval between each two sequential administrations of the continuous doses is 4 weeks, and 
 wherein the anti-human IL-31 RA antibody comprises an H chain variable region comprising CDR1 as set forth in SEQ ID NO: 1, CDR2 as set forth in SEQ ID NO: 2, and CDR3 as set forth in SEQ ID NO: 3, and an L chain variable region comprising CDR1 as set forth in SEQ ID NO: 4, CDR2 as set forth in SEQ ID NO: 5, and CDR3 as set forth in SEQ ID NO: 6. 
 
     
     
       12. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient, the method comprising subcutaneously administering to the patient a series of doses of an anti-human IL-31RA antibody comprising an H chain variable region comprising CDR1 as set forth in SEQ ID NO: 1, CDR2 as set forth in SEQ ID NO: 2, and CDR3 as set forth in SEQ ID NO: 3, and an L chain variable region comprising CDR1 as set forth in SEQ ID NO: 4, CDR2 as set forth in SEQ ID NO: 5, and CDR3 as set forth in SEQ ID NO: 6,
 wherein the amount of the anti-human IL-31RA antibody in each individual dose in the series is 30 mg/body, and 
 wherein the interval between each administration and the next is 4 weeks.